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CDK4/6 Inhibitor

Abemaciclib for Small Cell Lung Cancer

Phase 2

Recruiting

Led By Afshin Dowlati, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathology confirmed Retinoblastoma wild type tested by NGS or ctDNA.

Performance status: ECOG Performance status ≤ 2.

Must not have

HIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Abemaciclib. In addition, these subjects are at increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in subjects receiving combination antiretroviral therapy when indicated.

Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 (except alopecia, and neuropathy).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years from start of study.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Abemaciclib as a potential treatment for small cell lung cancer that has not responded to prior treatment or has relapsed.

Who is the study for?

This trial is for adults with certain types of lung cancer that haven't improved after chemotherapy. They should have a specific gene type (Rb wild-type), measurable disease, and be able to take pills orally. Participants need good organ function and can't join if they're pregnant, breastfeeding, or have serious medical conditions like severe lung disease or uncontrolled infections.

What is being tested?

The study tests Abemaciclib's effectiveness in shrinking tumors in patients with small cell lung cancer and related cancers that are resistant to chemo. It also examines the safety of this drug in those who've had no response to initial treatments or whose cancer returned post-chemo.

What are the potential side effects?

Abemaciclib may cause side effects such as diarrhea, fatigue, low blood counts leading to increased infection risk, liver issues, nausea, hair loss (alopecia), nerve pain (neuropathy), and potential harm to an unborn baby.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed to be retinoblastoma wild type.

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I can take care of myself but might not be able to do heavy physical work.

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My cancer did not respond or returned after platinum-based chemotherapy.

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I finished my radiotherapy at least 14 days ago and have recovered from its immediate effects.

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My cancer is a specific type of lung or related cancer, confirmed by lab tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not HIV-positive or not on antiretroviral therapy.

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My side effects from previous treatments are mild, except for hair loss or nerve issues.

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I do not have severe lung problems, major stomach surgery, Crohn's, ulcerative colitis, or chronic severe diarrhea.

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I do not have any active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.

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I do not have any severe illnesses that would stop me from following the study's requirements.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years from start of study.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years from start of study.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years from start of study. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR)

Secondary study objectives

Duration of response in all responders (DoR using RECIST 1.1)

Overall Survival (OS)

Progression Free Survival (PFS) according to RECIST 1.1

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AbemaciclibExperimental Treatment1 Intervention

* Subjects will receive Abemaciclib (200 mg), orally every 12 hours on days 1 to 28 of a 28-day cycle for a total of 56 doses per cycle. * Subjects will be evaluated after 4 weeks (1st cycle) and then every 8 weeks (2 cycles) with radiographic imaging to assess response to treatment.

0 / 11Eligibility criteria met